Enhanced needle

ABSTRACT

A port-a-cath needle adapted for determining the position of the needle prior to dispensing medical treatments is disclosed. Disclosed embodiments of the port-a-cath needle comprises a cannula, a hollow needle, and an inflatable balloon. The balloon is disposed at the distal end of the port-a-cath needle such that when the needle is inserted into a patient, the balloon may be inflated and the resistance pressure used to determine if the needle is inserted into the port chamber or a port-a-cath device or is surrounded by soft tissue. In certain embodiments, the balloon may be maintained in the inflated configuration in order to help retain the port-a-cath needle within the port chamber while treatment is delivered to the patient.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application of Ser. No.15/666,022 filed Aug. 1, 2017 and allowed on Aug. 17, 2020.

FIELD

Embodiments described herein relate to needles, ports, port-a-cathneedles, and other medical devices which may be useful for deliveringmedications and/or treatments to a patient. More particularly, someembodiments relate to an enhanced needle and method for confirming theposition of a needle within a port.

BACKGROUND AND SUMMARY

Port-a-cath needles are used to access port-a-cath devices. Port-a-cathdevices are typically permanently implanted under the skin of patientand facilitate delivery of chemotherapy drugs, IV fluids, medications,TPN, or other treatments. Port-a-cath devices typically include aninternal chamber, sealed with a self-sealing septum, and a catheter tubewhich connects the chamber to the vein of a patient. This allows forrepeated and/or periodic injections or infusions to be performed bypiercing the self-healing septum of the port chamber using an injectiondevice, such as a port-a-cath needle, and delivering the treatment intothe port chamber. The treatment then flows from the chamber through thecatheter tube into the veins of the patient. This arrangement allows forthe delivery of treatments which may be irritating or damaging to theskin or soft tissue as is commonly necessary when treating hematologyand/or oncology patients. Potential treatments include, but are notlimited to, vesicants, irritants, infusions, and other medications.Port-a-cath devices may also be known as or include implantable venousaccess devices and are known in the art.

Current port-a-cath needles are placed into the port chamber and may besecured in place using tape or dressing. Port-a-cath needles aretypically intended to extend down to the bottom of the port chamber tohelp confirm their placement into the correct location. A common problemassociated with this arrangement is that the port-a-cath needlessometimes do not extend to the bottom of the port chamber or may only bepartially placed in the port chamber or they may be placed in thesurrounding soft tissue rather than within the port chamber. This canlead to the release of medical treatments into soft tissue rather thanthe port chamber. This can cause tissue damage and even possible tissuenecrosis requiring surgery in the case of certain vesicantchemotherapies. The leakage of chemotherapy or other treatments into thesoft tissue under the skin has been known to cause the loss of breasttissue in some cases. There are also situations in which the port-a-cathneedle may become dislodged from the port chamber due to pulling on theneedle. In these cases, the chemotherapy may leak onto the soft tissueas well as the external skin creating a safety hazard as well aspossible tissue irritation/damage.

What is needed is a device, method, and/or system allowing medical staffto confirm the proper placement of the tip of a needle which can beperformed rapidly and with only modest amounts of training.

Embodiments disclosed include a port-a-cath needle with an inflatableballoon at the distal portion. This allows medical staff to inflate theballoon and use the resistance pressure to inflation to judge if theport-a-cath needle is inserted into the port chamber or soft tissue. Theinflatable balloon may additionally and/or alternatively help to securethe port-a-cath needle in the proper position and reduce the chance ofthe needle getting inadvertently pulled out of the port chamber. Themethods, devices, and system disclosed could serve to reduce errors intreatment delivery and allow for improved medical safety.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a port-a-cath device including an internal chamber andcatheter tube providing access to a vein.

FIG. 2A depicts one embodiment of a port-a-cath needle with a balloon inthe deflated configuration.

FIG. 2B shows a cut-away view of one embodiment of a port-a-cath needlewith a balloon in the inflated configuration.

FIG. 3A depicts an embodiment of a port-a-cath needle with a deflatedballoon.

FIG. 3B depicts an embodiment of a port-a-cath needle with an inflatedballoon.

FIG. 3C depicts one embodiment of a port-a-cath needle utilizing arupture membrane.

FIG. 3D depicts one embodiment of a port-a-cath needle showing thepositioning of the needle opening.

FIG. 4A depicts a simplified version of a port-a-cath needle connectedto a syringe.

FIG. 4B depicts a simplified version of a port-a-cath needle connectedto an infusion pump.

FIG. 5 depicts one embodiment of an alarm unit including a processor,indicator lights, and text message display.

FIG. 6 depicts a potential method of determining the location of aport-a-cath needle.

DETAILED DESCRIPTION

Disclosed embodiments of the port-a-cath needle 101 for the delivery ofmedical treatment into a port-a-cath device comprises a cannula 130, ahollow needle 110, and an inflatable balloon 120. In many embodiments,the cannula 130 forms an exterior portion of the port-a-cath needle 101and the balloon 120 is incorporated into the cannula 130. In theseembodiments, the hollow needle 110 is encased within the cannula 130 asshown in FIGS. 2A and 2B. The hollow needle 110 has a proximal end 114,which may connect to a standard hub 117 to connect the hollow needle 110to a syringe. The hollow needle 110 also has a distal end 112 which maybe used for delivering treatment 330 to a patient. The cannula has adistal balloon end 132 and a proximal pressure end 134. In someembodiments, the cannula proximal portion 134 may be a spout 136 influid communication with the main body of the cannula 130. In theembodiments depicted in FIGS. 2A and 2B, the space between the hollowneedle 110 and the cannula 130 is in fluid communication with theballoon 120 and a bulb 140 or other device for supplying pressure to theballoon 120. In these embodiments, the hollow needle 110 may be sealedwithin the cannula 130 such that the cannula 130 may receive pressurefrom the bulb 140 and communicate that pressure to the balloon 120without leaking any pressurized fluid. The materials and methods forsealing the hollow needle 110 to the cannula 130 are well known andunderstood in the art. The hollow needle 110 and the cannula 130 are ina fixed positional relationship relative to each other and do notsubstantially slide or rotate relative to each other.

In some embodiments, the proximate portion of the hollow needle 114 issealed to the proximate portion of the cannula 134 forming a proximatejunction 139 and the distal portion of the hollow needle 112 is sealedto the distal portion of the cannula 132 forming a distal junction 137.This arrangement isolates the interior of the hollow needle from theinterior of the cannula. In some embodiments, the distal junction 137connecting the distal portion of the cannula 132 to the distal portionof the hollow needle 112 may be tapered, angled, or chamfered to reduceor minimize catching, pulling, or otherwise causing strain on the skinor tissue of the patient or the septum of the port-a-cath device whenthe port-a-cath needle 101 is inserted into a patient and through theseptum 530 of a port-a-cath device.

FIG. 2A shows the exterior of an embodiment of a port-a-cath needle 101in which the cannula 130 forms the majority of the exterior of theport-a-cath needle 101. The cannula 130 seals around the majority of thehollow needle 110. The distal portion of the hollow needle 110 exits thecannula 130 so that treatment 330 may be delivered through opening 111.The proximal portion of the cannula 130 seals around the proximateportion of the hollow needle 110 such that pressure delivered to theproximal portion of the cannula 134 is transferred to the balloon 120.In some embodiments, the proximal portion of the cannula 134 maycomprise a separate spout 136 in fluid communication with the cannula130. The spout 136 may facilitate the connection of pressure bulb 140,clamp 150, and other components of the port-a-cath needle 101. In manyembodiments, spout 136 will be integrated into a single piece cannula130.

FIG. 2B shows a cut-away view of the embodiment disclosed in FIG. 2A.This figure clarifies the positional relationship between the hollowneedle 110 and the cannula 130 and shows that a narrow gap existsbetween the exterior wall of the hollow needle 110 and the interior wallof the cannula 130. This gap allows pressure applied to the proximalportion of the cannula 134 to be transferred to the balloon 120.

In other embodiments, the hollow needle 110 may form an exterior portionof the port-a-cath needle 101. In these embodiments, the inflatableballoon 120 is incorporated into the hollow needle 110 at the distal end112. In these embodiments, cannula 130 is in fluid communication withthe inflatable balloon 120 which allows the balloon 120 to be inflatedusing a bulb 140 or other device for delivering a liquid or gas underpressure to the balloon 120. In these embodiments, cannula 130 isdisposed within the hollow needle 110 as shown in FIGS. 3A-3D. FIGS.3A-3D also disclose multiple optional features of the port-a-cath needle101 which may be incorporated into many other embodiments of theport-a-cath needle 101.

Many embodiments will also comprise a valve, clamp 150, and/or screwdevice for optionally disrupting fluid communication between theinflatable balloon 120 and the exterior environment, thereby maintainingpressure within the balloon 120 and locking the balloon 120 in theinflated position.

When the balloon 120 is in the deflated configuration, it liessubstantially flush with the exterior surface of the port-a-cath needle101. This prevents the deflated balloon 120 from interfering withinserting the needle through the skin and soft tissue of the patient aswell as through the septum 530 of the port-a-cath chamber 520. In someembodiments, the balloon 120 may be slightly recessed relative to theexterior surface of the port-a-cath needle 101 while it is deflated. Theballoon 120 may be made of any material suitable for inserting into apatient. Many of the disclosed embodiments are intended for single useonly, thus the durability of the balloon material to withstand severalindependent rounds of being inflated and deflated is not a significantconcern.

The cannula 130 in fluid communication with the inflatable balloon 120allows the balloon 120 to be inflated and deflated. The cannula 130 maybe made of polymer, metal, silicon, rubber, or any other suitablematerial or combination of materials. Many embodiments will utilize amanual squeeze bulb 140 to deliver air under pressure to the balloon120, thereby inflating the balloon. The squeeze bulb 140 may beconnected to the cannula 130 using any of the connection methods anddevices known in the art. As is known in the art, squeezing the bulb 140will create pressure within the bulb 140. That pressure will then becommunicated through the cannula 130 to the balloon 120 causing theballoon 120 to inflate. This arrangement allows for the immediatedetection of any resistance to inflation of the balloon 120 by themedical staff. The level and nature of this resistance may inform themedical staff inflating the balloon 120 as to the positioning of theport-a-cath needle 101. As an example only, if the port-a-cath needle101 is inserted into the internal chamber 520 of a port-a-cath device510, the balloon 120 will be in a relatively empty or fluid-filled spacewith minimal solid objects exerting pressure on the balloon 120 andresisting its inflation. If the port-a-cath needle 101 is not insertedinto the internal chamber 520 of a port-a-cath device 510 and the distalportion of the port-a-cath needle 101 is surrounded by soft tissue 610,this soft tissue 610 will exert an external pressure on the balloon 120,thereby resisting its inflation. Similarly, if the port-a-cath needle101 is inserted only slightly into the port chamber 520 such that theballoon 120 is surrounded by the self-sealing septum 530, the resistanceto inflation will be significantly increased as compared to inflatingthe balloon 120 within the port chamber 520. The increase in resistancepressure can be detected by the medical staff as they attempt to inflatethe balloon 120 using the manual squeeze bulb 140. The detected increasein pressure informs the medical staff that the port-a-cath needle 101may be improperly positioned prior to delivering treatment 330. This canavoid the delivery of treatment 330 directly into the soft tissue 610 asopposed to the port-a-cath device 510 or veins 545 of the patient.Delivering treatment 330 when the port-a-cath needle 101 is not properlypositioned in the port-a-cath chamber 520 can result not only in wastedmedical materials, but some treatments 330 can irritate or damage thesurrounding tissues requiring additional medical attention and possiblysurgery.

Alternate embodiments may use alternative sources of pressurized air orother gases or liquids, such as saline 620 or other medicallyappropriate liquids, to inflate the balloon 120 instead of the manualsqueeze bulb 140. In these embodiments, a pressure regulator 250 may berequired in order to ensure that the balloon 120 is not maximallyinflated when the port-a-cath needle 101 is inserted into soft tissue610. A pressure regulator 250 may also prevent the balloon 120 frombeing over inflated, rupturing, or inflating too rapidly. If the balloon120 is significantly inflated while the port-a-cath needle 101 isinserted into soft tissue 610 rather than the port chamber 520, thiscould cause the patient to experience pain and, in some cases, thesurrounding tissue could be damaged by the physical pressure exerted bythe balloon 120. A pressure regulator 250 could be used in order toensure that only mild pressure is ever applied to inflate the balloon120, thereby reducing or eliminating the chance of damaging anysurrounding tissues. The pressure regulator 250 may be incorporateddirectly into the port-a-cath needle device or may be attached to apressurized line upstream of the port-a-cath needle 101.

Disclosed embodiments may rely on a pressure sensor 210 to monitor theamount of pressure resisting inflation of the balloon 120. The pressuresensor 210 may be disposed anywhere in fluid communication with thecannula 130 and balloon 120. In these embodiments, a pressure sensor 210and/or pressure sensor display 215 may be used to objectively inform themedical staff of the amount of resistance pressure as opposed to relyingon the subjective determination of the medical staff. The pressuresensor display 215 may be digital or analog. A pressure sensor 210, incombination with a pressure regulator 250, may also be used toautomatically adjust the amount of pressure applied to inflate theballoon 120.

In certain embodiments, a pressure sensor 210, in combination with aclamp 150, valve, or similar device could be used as a fail-safe inorder to ensure that the amount of pressure used to inflate the balloon120 never exceeds a pre-determined amount. In such embodiments, thepre-determined amount could be set at a pressure lower than the amountrequired to cause damage to any surrounding tissues in the event thatthe balloon 120 was surrounded by soft tissue 610 when pressure wasapplied to inflate the balloon 120.

In some embodiments, a processor 220 may be operably connected to apressure sensor 210 and be arranged to gather and analyze data from thepressure sensor 210. The processor 220 may be connected to an alarm 230or other form of notification system. The processor 220 may activate thealarm 230 in response to a predetermined condition. For example purposesonly, if the processor 220 determines that the data from the pressuresensor 210 is indicative of the balloon 120 being inflated whilesurrounded by tissue, the processor 220 may activate an alarm 230alerting the medical staff to the conditions. The alarm 230 may take theform of indicator lights 232, an audible alert, a text message display236, or any other manner of informing the staff. In some embodiments,the processor 220 may be able to determine if the balloon 120 ispositioned in the self-sealing septum 530 and may inform the staff toinsert the port-a-cath needle 101 deeper into the port chamber 520. Theprocessor 220 may also be connected to a pressure regulator 250 whichmay be automatically closed if the processor 220 detects a dangerouscondition such as excessively high pressure readings. In someembodiments, the processor 220 may control the pressure regulator 250 inorder to automate the inflation of the balloon 120. In theseembodiments, the processor 220 may allow pressure to begin inflating theballoon 120 while monitoring the resulting pressure data. If thepressure data corresponds with the balloon 120 inflating within the portchamber, the processor can alert the staff that the port-a-cath needle101 is properly positioned. If the processor 220 determines that thepressure data corresponds to the balloon 120 being inserted into theseptum 530 or the soft tissue 610, it can alert the medical staff tothese conditions and instruct them accordingly. The processor 220 maysimilarly be connected to a pressure release valve 170 and be arrangedto release the pressure in the balloon 120 if the pressure exceeds acertain threshold. This pre-determined threshold can be set to an amountof pressure less than the amount required to damage soft tissue 610.

In some embodiments, a pre-determined amount of pressurized air, orother gas or liquids, could be used to inflate the balloon 120 and theresulting pressure could be used in order to determine the properplacement of the needle 110. For example purposes only, if 1 cc ofpressurized saline were used to inflate the balloon 120, the resultingresistance pressure would be expected to be lower if the balloon 120were inflated within the port-a-cath chamber 520 as opposed to beinginflated while surrounded by soft tissue 610 or the port septum 530.

In alternative embodiments, a rupture membrane 160 may be incorporatedinto the port-a-cath needle 101. This represents a safe andcomparatively low-cost option for preventing excessive pressure frombeing used to inflate the balloon 120. In this embodiment, a rupturemembrane 160 could be incorporated into the cannula 130 such that if theamount of pressure in the cannula 130 were to exceed a certain pressurethreshold, the rupture membrane 160 would burst, releasing thepressurized air or other gas or liquid, within the cannula 130 andballoon 120 to the outside environment. In certain embodiments, it maybe advantageous to position a rupture membrane 160 at the proximateportion of the cannula 134 such that the rupturing of the membrane wouldminimally impact the hollow needle 110 or the treatment.

Some embodiments of the port-a-cath needle 101 may comprise an externalhilt 163 for ensuring that the port-a-cath needle 101 may only beinserted a certain depth into the patient.

In addition to inflating the balloon 120 with air, other gasses orliquids may be used alternatively or as well. In some embodiments, aself-contained reservoir of saline solution or other medicallyappropriate liquid may be used to inflate the balloon. In alternativeembodiments, inflating the balloon with a particular liquid mayfacilitate identifying the position of the needle using scanningtechnologies such as ultrasound, fluoroscopy, X-ray, CT, or MRI.

In addition to using the resistance pressure when inflating the balloon120 as an indicator of the position of the port-a-cath needle 101, insome embodiments, a valve, clamp 150, or other locking device may beused to maintain the balloon 120 in its inflated configuration. If theballoon 120 is inflated while it is inside the port chamber 520, theinflated balloon 120 may prevent accidental withdrawal of theport-a-cath needle 101 through the self-sealing septum 530. This may beparticularly useful when delivering infusions which require theport-a-cath needle 101 to remain in place for an extended period oftime. These two benefits of the balloon 120 may be utilized in severalmethods. FIG. 5 outlines one such method. In method 400, the medicalstaff inserts the port-a-cath needle into a patient 410. Then themedical staff may attempt to inflate the balloon 420 and monitor theresistance pressure to inflation 430. The medical staff may use theresulting resistance pressure in order to determine whether theport-a-cath needle has been properly inserted into the port chamber oris surrounded by soft tissue 440. Once the port-a-cath needle has beenproperly inserted into the port chamber, the balloon may be inflated andthe medical staff may tighten a valve or engage a clamp 450 in order tomaintain the balloon in the inflated configuration. This will preventthe port-a-cath needle from being accidentally withdrawn through theport chamber septum. In some embodiments, the port-a-cath needle 101 maybe bent at least 30°, or at least 45°, or at least 60°, or at least 90°so that the port-a-cath needle 101 may be taped or otherwise secured inposition for the duration of an infusion.

The port-a-cath needle 101 may be made from conventional materials suchas stainless steel as is known in the art. In some embodiments, theport-a-cath needle 101 may be made using materials suitable for medicalimplants such as titanium, and/or zirconium. In some cases, theport-a-cath needle 101 may remain in position for an extended period oftime, such as when delivering an infusion. In these cases, potentialallergic reactions may be avoided by using materials that are less than10% or less than 5% or less than 1% or less than 0.1% nickel, cobalt,chromium, aluminum, vanadium, niobium and/or combinations or alloysthereof.

The hollow needle 110 may utilize any type of tip 113. The hollow needle110 may include a Huber point tip, beveled tip including but not limitedto 20° bevel tip, domed tip, domed side hole tip, eccentric tip or anyother needle tip. Preferred embodiments will use a non-coring tip 113with an opening 111 for dispersing treatments 330 disposed on the sideof the hollow needle 110. In most embodiments, the balloon 120 will bedisposed slightly proximally to the opening 111 in order to ensure thatthe opening 111 is at least as deeply inserted into the port chamber 520as the inflatable balloon 120. In alternative embodiments, the balloon120 may be disposed distally of the opening 111.

The bore length of the hollow needle 110 may be as short as ⅜″, or asshort as ½″, or as short as ⅝″, or as short as ¾″, or as short as 1″. Insome embodiments, the bore length may also be as long as 1″, or as longas 1¼″, or as long as 1½″, or as long as 2″, or as long as 3″ or evenlonger.

The port-a-cath needle 101 may incorporate a standard twist-mount hub117 for connecting a standard twist-mount syringe 310 or may incorporatea slip or push-on connection, luer lock connection, or any otherappropriate connection known in the art. In these embodiments, aconventional syringe 310 may be used to deliver the treatment 330through the hollow needle 110 into the port-a-cath chamber 520. In someembodiments, the syringe 310 may be replaced with an infusion pump 320or other device for delivering the treatment 330. In these embodiments,the port-a-cath needle hub 117 must be appropriate to connect to thedesired treatment delivery device. FIGS. 4A and 4B depict highlysimplified versions of the port-a-cath needle connected to a syringe andinfusion pump respectively.

Alternative embodiments will comprise an automatic port-a-cath needleinjection device which may or may not include an inflatable balloon asdescribed above. The training and certification process frequentlyrequired for medical staff to utilize port-a-cath devices is nottypically required for all medical staff. In some situations, a patientmay have a port-a-cath device implanted but the available medical staffis not trained, certified, and/or approved to access the port-a-cathdevice to deliver treatment. In some instances, this can result in apatient receiving multiple painful injections or attempted injectionswhen a single injection to access the port-a-cath device would provide abeneficial alternative.

An automatic port-a-cath injection device comprises a sensor fordetecting the implanted port-a-cath device. Detection of the port-a-cathdevice is traditionally performed manually by medical staff. Standardport-a-cath devices contain a number of physical protrusions which canbe physically detected by pressing on the skin of the patient until theprotrusions are felt by the medical staff. The location of theport-a-cath chamber can then be extrapolated based on the locations ofthe protrusions.

The disclosed automatic port-a-cath injection device comprises sensorsfor automatically detecting the location of the implanted port-a-cathdevice. The automatic injection device can detect the location of theimplanted port-a-cath device and inform the medical staff of the properlocation and angle of the automatic injection device in order toaccurately and reliably insert a port-a-cath needle into the port-a-cathdevice implanted within a patient.

In order to automatically detect the proper location of the port-a-cathdevice, the automatic port-a-cath injection device uses at least one,and possibly more than one, type of sensor capable of locating theport-a-cath device. Possible port-a-cath device sensors include magneticsensors, light and photon-based sensors, ultrasound devices,electromagnetic field based sensors, and near field communicationdevices. Many of these sensors necessarily contain integraltransmission/emission devices which are well known in the art. Thesesensors can be arranged to detect a standard port-a-cath device, whichtypically contains polymer and/or metal materials which may be readilydistinguished from the patient's tissues by an arrangement oftransmission/detection devices.

In some embodiments, a modified port-a-cath device may be used whichcontains an RFID chip, signal transmission device, or near fieldcommunication device integrated into the implanted port-a-cath device.Use of a modified port-a-cath device may facilitate the port-a-cathdevice being located by a sensor in the automatic port-a-cath injectiondevice.

The port-a-cath device sensors are operably connected to a processorwhich is configured to analyze the sensor data and provide an output tothe medical staff regarding the location of the port-a-cath devicerelative to the automatic port-a-cath injection device. This output caninclude at least location data regarding the relative location of theport-a-cath device as well as angular alignment data in order to ensurethat the port-a-cath needle is accurately inserted into the internalport-a-cath chamber. The incorporation of angular alignment data helpsto avoid the potential system of the automatic port-a-cath injectiondevice being properly located over the implanted port-a-cath device butthe port-a-cath needle being inserted into the patient at an angle whichcauses the port-a-cath needle to miss the septum of the internalport-a-cath chamber.

Once the automatic two devices are properly aligned, the automaticinjection device indicates the proper alignment to the medical staff whoinserts a port-a-cath needle into the patient, accessing the port-a-cathdevice in order to deliver treatment to the port-a-cath chamber. In someembodiments, the automatic port-a-cath injection device contains amotor, actuator, piston, or similar device for inserting a port-a-cathneedle into the patient automatically once the device is properlyaligned. In some of these embodiments, the automatic port-a-cathinjection device is connected to a supply of pressurized air or otherfluid. In these embodiments, the pressurized air may be used to providethe force necessary for inserting the port-a-cath needle into thepatient. Certain embodiments insert a port-a-cath needle which comprisesan inflatable balloon as described above. In these embodiments, the samepressurized fluid which drives the injection of the port-a-cath needlemay be used to inflate the balloon in order to confirm proper placementof the port-a-cath needle.

The automatic port-a-cath injection device is configured to receivedisposable needles, including disposable port-a-cath needles with aninflatable balloon. These needles fit into a carriage which allows theautomatic port-a-cath injection device to insert the port-a-cath needlesinto the patient without contaminating the injection device itself. Inmany embodiments, the injection device comprises a housing which hasretaining clips for single-use medical tubing used for deliveringtreatment to the patient through the port-a-cath needle.

Certain embodiments of the automatic port-a-cath injection devicecomprise a pressure regulator, a pressure sensor, a port-a-cath devicesensor, a carriage for inserting a port-a-cath needle prior to insertioninto the patient, an actuator for inserting the port-a-cath needle intothe patient, and a tube in fluid communication with the port-a-cathneedle which allows treatment to be delivered through the automaticallyinjected port-a-cath needle.

Disclosed embodiments relate to a port-a-cath needle comprising acannula wherein the cannula has a distal portion and a proximateportion; a hollow needle wherein the hollow needle has a distal portionand a proximate portion; and an inflatable balloon, wherein the balloonis in fluid communication with the cannula. In certain embodiments, thehollow needle is at least partially sealed within the interior of thecannula, wherein the proximate portion of the hollow needle is sealed tothe proximate portion of the cannula forming a proximate junction andthe distal portion of the hollow needle is sealed to the distal portionof the cannula forming a distal junction, and wherein the interior ofthe hollow needle is isolated from the interior of the cannula, andwherein the inflatable balloon is positioned at the distal portion ofthe cannula. In some embodiments, the distal junction is tapered. Incertain embodiments, the cannula has an exterior surface and theinflatable balloon is arranged to be substantially flush with theexterior surface of the cannula when the balloon is not inflated.Disclosed embodiments may also relate to a port-a-cath needle whereinthe inflatable balloon is positioned at the distal portion of the hollowneedle.

Some embodiments, may further comprise a squeeze bulb in fluidcommunication with the proximate portion of the cannula; a clamp whereinthe clamp is arranged to optionally restrict fluid communication withthe cannula; a processor; a pressure sensor, wherein the processor isoperably connected to the pressure sensor and configured to analyze datafrom the pressure sensor; a source of pressurized fluid in fluidcommunication with the proximate portion of the cannula; a pressureregulator, wherein the processor is operably connected to the pressureregulator; a clamp wherein the clamp is arranged to optionally restrictfluid communication of the cannula, wherein the processor is operablyconnected to the clamp; a rupture membrane in fluid communication withthe cannula, wherein the membrane is arranged to rupture in response topressure exceeding a pre-determined threshold; a syringe in fluidcommunication with the hollow needle; and/or an infusion pump in fluidcommunication with the hollow needle. In certain embodiments, the hollowneedle has a non-coring tip.

Disclosed embodiments may relate to a port-a-cath system comprising avascular access port comprising an internal chamber, wherein theinternal chamber is sealed using a self-sealing septum and wherein theinternal chamber is in fluid communication with a catheter; and aport-a-cath needle, wherein the port-a-cath needle comprises a cannulawherein the cannula has a distal portion and a proximate portion; ahollow needle wherein the hollow needle has a distal portion and aproximate portion; and an inflatable balloon, wherein the balloon is influid communication with the cannula. Some embodiments may furthercomprise a squeeze bulb in fluid communication with the cannula.

The terms and descriptions used herein are set forth by way ofillustration only and are not meant as limitations. Those skilled in theart will recognize that many variations are possible within the spiritand scope of the invention as defined in the following claims, and theirequivalents, in which all terms are to be understood in their broadestpossible sense unless otherwise indicated.

What is claimed is:
 1. A port-a-cath system comprising: a vascularaccess port comprising an internal chamber, wherein the internal chamberis sealed using a self-sealing septum and wherein the internal chamberis in fluid communication with a catheter; and a port-a-cath needlecomprising: a cannula wherein the cannula has a distal portion and aproximate portion; a hollow needle; and an inflatable balloon, whereinthe inflatable balloon is in fluid communication with the cannula;wherein the hollow needle is at least partially sealed within aninterior of the cannula and wherein an interior of the hollow needle isisolated from the interior of the cannula, and wherein the inflatableballoon is positioned at the distal portion of the cannula and whereinthe hollow needle and the cannula are in a fixed positional relationshiprelative to each other and do not substantially slide or rotate relativeto each other.
 2. The port-a-cath system of claim 1 wherein the hollowneedle comprises a non-coring tip.
 3. The port-a-cath system of claim 1,further comprising a squeeze bulb in fluid communication with thecannula.
 4. The port-a-cath system of claim 1, further comprising aprocessor.
 5. The port-a-cath system of claim 4, further comprising apressure sensor, wherein the processor is operably connected to thepressure sensor and configured to analyze data from the pressure sensor.6. The port-a-cath system of claim 1, further comprising a source ofpressurized fluid in fluid communication with the cannula.
 7. Theport-a-cath system of claim 4, further comprising a pressure regulator,wherein the processor is operably connected to the pressure regulator.8. The port-a-cath system of claim 4, further comprising a clamp whereinthe clamp is arranged to optionally restrict fluid communication of thecannula, wherein the processor is operably connected to the clamp. 9.The port-a-cath system of claim 1, further comprising a rupture membranein fluid communication with the cannula, wherein the membrane isarranged to rupture in response to pressure exceeding a pre-determinedthreshold.
 10. The port-a-cath system of claim 1 wherein the distalportion of the hollow needle is tapered.
 11. The port-a-cath system ofclaim 1 wherein the hollow needle lacks a stylet.
 12. The port-a-cathsystem of claim 1 wherein the hollow needle comprises an opening on aside wall of the hollow needle.
 13. The port-a-cath system of claim 12wherein the inflatable balloon positioned at the distal portion of thecannula is positioned on the same side wall of the hollow needle as theopening of the hollow needle.
 14. The port-a-cath system of claim 1,wherein the cannula has an exterior surface and the inflatable balloonis arranged to be substantially flush with the exterior surface of thecannula when the inflatable balloon is not inflated.
 15. The port-a-cathsystem of claim 1, wherein the inflatable balloon is positioned at thedistal portion of the hollow needle.
 16. The port-a-cath system of claim1, further comprising a squeeze bulb in fluid communication with theproximate portion of the cannula.
 17. The port-a-cath system of claim 1,further comprising a syringe in fluid communication with the hollowneedle.
 18. The port-a-cath system of claim 1 wherein the port-a-cathneedle is configured to inflate the inflatable balloon with a medicallyappropriate liquid.
 19. The port-a-cath system of claim 18 wherein themedically appropriate liquid comprises saline.
 20. A port-a-cath needlecomprising: a cannula wherein the cannula has a distal portion and aproximate portion; a hollow needle; and an inflatable balloon, whereinthe inflatable balloon is in fluid communication with the cannula;wherein the hollow needle is at least partially sealed within aninterior of the cannula and wherein an interior of the hollow needle isisolated from the interior of the cannula, and wherein the inflatableballoon is positioned at the distal portion of the cannula and whereinthe hollow needle and the cannula are in a fixed positional relationshiprelative to each other and do not substantially slide or rotate relativeto each other.